Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Data acquisition unit (for CU-171R, CU-172R)
NIHON KOHDEN CORPORATION
JA-170P
In Commercial Distribution

  • 04931921004593 ()
JA-170P

  • General-purpose multi-parameter bedside monitor
EPAD Acquisition red left short cable
SAFEOP SURGICAL, INC.
EPAD
Not in Commercial Distribution

  • 00851641007121 ()
100027

  • Evoked-potential graphic recording system
EPAD Acquisition white right short cable
SAFEOP SURGICAL, INC.
EPAD
Not in Commercial Distribution

  • 00851641007114 ()
100028

  • Evoked-potential graphic recording system
EPAD Acquisition white right long cable
SAFEOP SURGICAL, INC.
EPAD
Not in Commercial Distribution

  • 00851641007077 ()
100024

  • Evoked-potential graphic recording system
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-04-00-000
In Commercial Distribution

  • 00817100020438 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-02-03-04-000
In Commercial Distribution

  • 00817100020421 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ-04-01-00-000
In Commercial Distribution

  • 00817100020414 ()


  • Diagnostic x-ray digital imaging system workstation application software
Software, Opal Acquire Image Acquisition Software.
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
OPALACQ 04-02-01-000
In Commercial Distribution

  • 00817100020186 ()


  • Diagnostic x-ray digital imaging system workstation application software
Acquisition unit of NExT Station Advanced
EB NEURO SPA
B9630096005
In Commercial Distribution

  • 08056446901120 ()


  • Electromyograph
  • Evoked-potential graphic recording system
PC-ECG Acquisition Device with Trigger, 5V
NORAV MEDICAL LTD.
1200T
In Commercial Distribution

  • 07290110250263 ()
1200T2-D-00-01

  • Electrocardiographic signal amplifier
Clarity® Acquisition Station (310C00) - Refurbished
Elekta Solutions AB
9100-00060-R
Not in Commercial Distribution

  • 07540180000030 ()


  • Ultrasound patient positioning system
NEXIVA 18 GA X 1.75 IN HF SINGLE PORT
BECTON, DICKINSON AND COMPANY
383520
In Commercial Distribution

  • 50382903835206 ()
  • 00382903835201 ()
  • 30382903835202 ()
383520

  • Peripheral intravenous cannula
Cautery, Suction Coagulation Tip, 33cm,HF port, suction channel
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
11-1240
In Commercial Distribution

  • 00848657012577 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
Cautery, Suction Coagulation Tip, 45cm,HF port, suction channel
NATIONAL ADVANCED ENDOSCOPY DEVICES, INC.
11-1240-45
In Commercial Distribution

  • 00848657014076 ()


  • Endoscopic electrosurgical electrode, monopolar, reusable
CON OBT FOR TAP/FEN HF PANO SCOPE SHEATH
ARTHREX, INC.
AR-3375-4207
In Commercial Distribution

  • 00888867431331 ()
AR-3375-4207

  • Rigid optical arthroscope, reusable
5mm 33cm Spatula Tip Electrode, Ceramic Tip, HF Post
Surgical Direct, Inc.
SD11709C
In Commercial Distribution

  • B382SD11709C0 ()

  • Length: 33 Centimeter
  • Outer Diameter: 5 Millimeter
SD11709C

  • Endoscope sheath, reusable
IRIS FCP 1X2 XD .5MM,4 INCHES HF CVD
SKLAR CORPORATION
66-3541
In Commercial Distribution

  • 10649111096075 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
CON OBT FOR TAP/FEN HF 4MM SCOPE SHEATH
ARTHREX, INC.
AR-3375-4007
In Commercial Distribution

  • 00888867030459 ()
AR-3375-4007

  • Endoscope sheath, reusable
CON OBT F/TAP/FEN HF 3MM SCOPE SHEATH
ARTHREX, INC.
AR-3375-0307
In Commercial Distribution

  • 00888867030220 ()
AR-3375-0307

  • Endoscope sheath, reusable
TROCAR F/TAP/FEN HF 4mm STORZ SCOPE SHTH
ARTHREX, INC.
AR-3322
In Commercial Distribution

  • 00888867029507 ()
AR-3322

  • Orthopaedic trocar blade, reusable
SHEATH,HF,TAP/FEN,2STPCK F/STORZ 4mm SCP
ARTHREX, INC.
AR-3320-02
In Commercial Distribution

  • 00888867029484 ()
AR-3320-02

  • Endoscope sheath, reusable
SHEATH,HF,TAP/FEN,1STPCK F/STORZ 4mm SCP
ARTHREX, INC.
AR-3320-01
In Commercial Distribution

  • 00888867029477 ()
AR-3320-01

  • Endoscope sheath, reusable
SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
ARTHREX, INC.
AR-3371-4000
In Commercial Distribution

  • 00888867030145 ()
AR-3371-4000

  • Endoscope sheath, reusable
SHEATH,HF,TAP/FEN,2 STPCK FOR 3MM SCOPE
ARTHREX, INC.
AR-3373-0302
In Commercial Distribution

  • 00888867198555 ()
AR-3373-0302

  • Endoscope sheath, reusable
SHEATH,HF,TAP/FEN,1 STPCK FOR 3MM SCOPE
ARTHREX, INC.
AR-3373-0301
In Commercial Distribution

  • 00888867198548 ()
AR-3373-0301

  • Endoscope sheath, reusable
CON OBT F/TAP/ FEN HF 4.8MM SCOPE SHEATH
ARTHREX, INC.
AR-3375-5007
In Commercial Distribution

  • 00888867216846 ()
AR-3375-5007

  • Rigid optical arthroscope, reusable
SHEATH,HF,TAP/FEN,2 STPCK FOR 4MM SCOPE
ARTHREX, INC.
AR-3373-4002
In Commercial Distribution

  • 00888867198579 ()
AR-3373-4002

  • Endoscope sheath, reusable
SHEATH,HF,TAP/FEN,1 STPCK FOR 4MM SCOPE
ARTHREX, INC.
AR-3373-4001
In Commercial Distribution

  • 00888867198562 ()
AR-3373-4001

  • Endoscope sheath, reusable
SHEATH,HF,TAP/FEN,2 STPCK F/4.8MM SCOPE
ARTHREX, INC.
AR-3373-5002
In Commercial Distribution

  • 00888867206984 ()
AR-3373-5002

  • Endoscope sheath, reusable
SHEATH,HF,TAP/FEN,1 STPCK F/4.8MM SCOPE
ARTHREX, INC.
AR-3373-5001
In Commercial Distribution

  • 00888867206977 ()
AR-3373-5001

  • Endoscope sheath, reusable
Standard Cold Knife (DO NOT USE with HF CURRENT)
Surgical Direct, Inc.
SD43909
In Commercial Distribution

  • B382SD439090 ()
SD43909

  • Endoscope sheath, reusable
RPW V-ACTOR HF HANDPIECE INCL V25 AND V40 TRANSMITTERS
DJO, LLC
19365
In Commercial Distribution

  • 00190446650973 ()


  • Pneumatic orthopaedic extracorporeal shock wave therapy system
5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 110mm
AMEDICA CORPORATION
H
Not in Commercial Distribution

  • M555287509110 ()

  • Length: 110 Millimeter
  • Outer Diameter: 7.5 Millimeter
28-7509-110

  • Spinal bone screw, non-bioabsorbable
5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 100mm
AMEDICA CORPORATION
H
Not in Commercial Distribution

  • M555287509100 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 100 Millimeter
28-7509-100

  • Spinal bone screw, non-bioabsorbable
5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 90mm
AMEDICA CORPORATION
H
Not in Commercial Distribution

  • M555287509090 ()

  • Length: 90 Millimeter
  • Outer Diameter: 7.5 Millimeter
28-7509-090

  • Spinal bone screw, non-bioabsorbable
5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 80mm
AMEDICA CORPORATION
H
Not in Commercial Distribution

  • M555287509080 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 80 Millimeter
28-7509-080

  • Spinal bone screw, non-bioabsorbable
5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 70mm
AMEDICA CORPORATION
H
Not in Commercial Distribution

  • M555287509070 ()

  • Length: 70 Millimeter
  • Outer Diameter: 7.5 Millimeter
28-7509-070

  • Spinal bone screw, non-bioabsorbable
5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 60mm
AMEDICA CORPORATION
H
Not in Commercial Distribution

  • M555287509060 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 60 Millimeter
28-7509-060

  • Spinal bone screw, non-bioabsorbable
5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 55mm
AMEDICA CORPORATION
H
Not in Commercial Distribution

  • M555287509055 ()

  • Length: 55 Millimeter
  • Outer Diameter: 7.5 Millimeter
28-7509-055

  • Spinal bone screw, non-bioabsorbable
5.5 HF Monoaxial Tapered, triple Lead Screw - ø7.5mm, 50mm
AMEDICA CORPORATION
H
Not in Commercial Distribution

  • M555287509050 ()

  • Outer Diameter: 7.5 Millimeter
  • Length: 50 Millimeter
28-7509-050

  • Spinal bone screw, non-bioabsorbable
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